OTCQB: CYTR CORPORATE OVERVIEW JANUARY 2022
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OTCQB: CYTR
CORPORATE OVERVIEW
JANUARY 2022
CytRx Safe Harbor Statement
THIS PRESENTATION CONTAINS FORWARD-LOOKING STATEMENTS THAT
INVOLVE CERTAIN RISKS AND UNCERTAINTIES. ACTUAL RESULTS
COULD DIFFER MATERIALLY FROM THOSE EXPRESSED OR IMPLIED IN
THESE FORWARD-LOOKING STATEMENTS AS A RESULT OF VARIOUS
RISKS AND UNCERTAINTIES, INCLUDING THOSE RISK FACTORS
DISCUSSED IN THE ANNUAL AND QUARTERLY REPORTS THAT CYTRX
FILES WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION.
2
CytRx Highlights
▪ CytRx appoints Dr. Stephen Snowdy as Chief Executive Officer, effective January
10, 2022
▪ CytRx’s milestone and royalty agreement with Orphazyme for arimoclomol could
represent potential near term payments to CytRx
▪ Orphazyme ( ORPH – Nasdaq) has submitted a Marketing Authorisation Application
with EMEA authorities for arimoclomol for NPC and recently held a Type A meeting
with the FDA
▪ ImmunityBio (IBRX) recently announced updates on Cohort C of its Phase 2
registrational-intent study for first-line and second-line locally advanced or
metastatic pancreatic cancer, which includes aldoxorubicin. In addition, they are
pursuing clinical trials in glioblastoma, triple negative breast cancer and head and
neck
▪ Centurion BioPharma is an oncology drug development company (wholly-owned
subsidiary of CytRx) focused on cancer and has completed extensive pre-clinical
work for its ultra high potency LADRTM drug candidates and albumin companion
diagnostic (ACDx). Centurion is under CDA with two multi-billion dollar
pharma/biotech companies.
3
CytRx has potential milestone/royalty
payments and an oncology subsidiary,
Centurion BioPharma
Orphazyme
Orphazyme: Potential Milestones plus royalties on
Milestones
and Royalties arimoclomol
ImmunityBio
Milestones
ImmunityBio: $343M in potential milestones; plus
and Royalties royalties on aldoxorubicin
Centurion
BioPharma
Oncology drug development with a companion
Pipeline diagnostic
Centurion BioPharma is a wholly-owned subsidiary of CytRx
4CytRx milestones and royalties from
Orphazyme for Arimoclomol
Orphazyme
Orphazyme: Potential milestones
Milestones
and Royalties in addition to royalties on arimoclomol
Niemann-Pick disease (“NPC”)
• Orphazyme submitted an MAA with the EMA for arimoclomol for NPC, with European
regulatory CHMP opinion expected in Q1/22 and anticipated approval decision and launch in
H1 2022
• Orphazyme filed an NDA with the FDA with Priority Review and received a Complete
Response Letter on June 17, 2021; they held a Type A meeting with the FDA in Oct 2021
and are now formulating a plan to address the FDA’s concerns and then file an NDA in 2022
• Orphazyme launched an Early Access Program for NPC in January 2020 to further accelerate
access to treatment with arimoclomol for people living with NPC. They anticipate related net
sales in France of approx. $5 - $6 million in 2021
• Total worldwide patients approximately 3,000.
• Expected price range is $300,000 - $600,000; EU market potential $300 Million.
• Go to market in EU H1 2022.
5Source: www.orphazyme.com 6
Orphazyme preparing for
commercialization in 2022 for arimoclomol
Orphazyme: Preparing for commercialization in 2022
Expected resubmission
ARIMOCLOMOL: of NDA for NPC to
APPROACHING THE MARKET Anticipated FDA, 2022
FOR 1st of 2 RARE DISEASE launch in EU for
Expected CHMP
INDICATIONS NPC, H1 2022
opinion in EU,
Q1 2022
Type A meeting with
the FDA, Oct 2021
Source: www.orphazyme.com 7CytRx potential milestones and royalties
from ImmunityBio for aldoxorubicin
ImmunityBio
Milestones
ImmunityBio: up to $343M in milestones
and Royalties In addition to royalties on aldoxorubicin
• ImmunityBio has highlighted aldoxorubicin as one of three separate modalities of its
platform.
• ImmunityBio recently announced positive results of its phase 2 registrational -intent study
using aldoxorubicin in combination with immunotherapy in metastatic pancreatic cancer,
which is now fully enrolled. 90% of the evaluable patients for Cohort C exceeded the
historical survival rates.
• ImmunityBio, to date, is using aldoxorubicin in studies in head and neck and triple
negative breast cancer, and has submitted a P 1/2 protocol with the FDA for glioblastoma,
in addition to metastatic pancreatic cancer.
• CytRx is entitled to increasing double-digit royalties on aldoxorubicin for soft tissue
sarcomas and increasing single-digit royalties for all other indications
• ImmunityBio is reviewing options in Soft Tissue Sarcoma.
8CytRx partnered Pipeline
with ImmunityBio - aldoxorubicin
Aldoxorubicin Preclinical Phase 1 Phase 2 Phase 3
2nd-Line Soft Tissue Sarcoma Ph 3 – Completed; ImmunityBio has IND
Combo with ifosfamide – STS Ph 1b/2 – ImmunityBio has IND
Combination Trials with Immunotherapy
Pancreatic Cancer Ph 2/3 – Cohort C survival data expected Q1/22
Triple Negative Breast Cancer Ph 1/2 – Ongoing
Head and Neck Cancer Ph 1/2 – Ongoing
Recurring Glioblastoma Ph 2 completed– Initiated a protocol
9Update from ImmunityBio on Metastatic
Pancreatic Cancer study QUILT-88
Metastatic Pancreatic Cancer QUILT-88: increased survival rate with no
other approved treatment options
▪ QUILT 88 study is a randomized, three cohort, open-label registrational-intent study that
evaluates the comparative efficacy and overall safety of standard-of-care chemotherapy
versus stand-of-care chemo in combination with PD-L1 t-hank, Anktiva (N-803), and
aldoxorubicin in subjects with locally advanced or metastatic pancreatic cancer
▪ In October 2021, ImmunityBio announced that Cohort C (the third Cohort) was fully enrolled
and of the evaluable patients, 90% (43/48) have exceeded the historical survival rates of
approx. 2 months with standard-of-care chemo. Based on this data and the significant unmet
medical need, they submitted an amendment to the FDA to increase enrollment in Cohort C,
and enrollment is actively ongoing
▪ The interim results of Cohort C have been selected for presentation at the ASCO
Gastrointestinal Cancers Symposium in January 2022
10Centurion BioPharma Highlights
Centurion is a private, preclinical-stage oncology-focused biotechnology company pioneering the
development of ultra-high potency cytotoxins with a diagnostic for patients with advanced solid malignancies
Centurion’s LADRTM technology was developed by our Freiburg, Germany laboratory personnel who were early
innovators in developing acid sensitive linkers attached to cytotoxins
Our 4 preclinical product candidates LADR-7, LADR-8, LADR-9, and LADR-10 were developed by us
exclusively, as well as our diagnostic ACDx (Albumin Companion Diagnostic)
Centurion retains worldwide development and commercialization rights to all of its product candidates
Total capital investment to date in the LADR program and the diagnostic ACDx is over $20 million
Our plans are to initiate IND enabling studies and the clinical Phase 1-2 trial(s) with our diagnostic ACDx
11CytRx subsidiary Centurion BioPharma has
an oncology preclinical pipeline and
diagnostic
Centurion
BioPharma
Oncology drug development with a companion
Pipeline diagnostic
LADRTM (linker activated drug release) albumin binding drug
conjugates
LADR-7 (auristatin)
LADR-8 (auristatin)
LADR-9 (maytansinoid)
LADR-10 (maytansinoid)
Albumin companion diagnostic (ACDx)
identifies tumors eligible for treatment with LADRTM
12LADR™ Mechanism of Action
Cytotoxic Albumin
Agent Linker
2
1 Rapid and specific
binding to 3
Cytotoxic
Agent Linker circulating albumin
Drug-linker conjugate Tumor cells
is infused
4
Albumin transports
drug to the tumor
and surrounding
Linker dissolves in the acidic (low pH) microenvironment
environment, releasing the drug payload
13Centurion BioPharma Pipeline
▪ ACDx and four ultra high potency LADR™ drugs were selected for development
▪ Non-GMP batches made and next step is technology transfer to make GMP material
▪ IND enabling studies can be initiated for 4 lead candidates. An IND submission is targeted for 2023 and starting of
our Phase 1-2 clinical trial in the latter half of 2023.
▪ Long term patent protection (2035-2038) for LADR™ technology, drug candidates, and diagnostic
LADR™ Albumin Binding Drug Preclinical Phase 1 Phase 2
Conjugates
Auristatin Program
LADR-7
LADR-8
Maytansinoid Program
LADR-9
LADR-10
Companion Diagnostic –
ACDx identifies patients across solid tumors
which have the potential to respond
14Auristatin and Maytansinoid LADR™s Are
Efficacious in Different Xenograft Tumor Models
▪ Breast ▪ NSCLC (lung)
▪ Head and Neck ▪ Ovarian
▪ Melanoma ▪ Renal
Pes et al., Journal of Controlled Release (2019) 296:81 and Supplemental Material; Poster LADR 9 and 10
15Recent and Upcoming Catalysts
2021–2022
✓Q4 2021: Type A meeting with FDA for NPC
✓Q4 2021: ImmunityBio announced complete enrollment of Cohort C on the
metastatic pancreatic cancer trial, and 90% of evaluable patients
exceeded the historical survival rates of approx 2 months. They are
submitting an amendment to increase enrollment
Q1 2022: Orphazyme expecting European regulatory CHMP opinion for
arimoclomol in NPC
▪ H1 2022: Upon EU approval, CytRx is to receive a $4 million milestone
payment
▪ 2022: Expected FDA resubmission of NDA for NPC
16Financial Summary
▪ Cash Position – ( 09/30/21) $16.5M
▪ No Debt
▪ Shares Outstanding - common 38.8M
▪ - preferred 8,240
▪ Convertible into 9.3 M common
▪ Options Weighted-average strike price: $8.15 2.9M
▪ Investment Option Price of $0.88 per share 11.4 M
17Summary
▪ Orphazyme could deliver milestones and royalties
▪ ImmunityBio could deliver milestones and royalties
▪ Cash burn rate is ~$377k per month, excluding
possible liquidated damages or dividends
▪ Potential to shelter future income with non-restrictive
net-operating carry-forward losses (“NOL’s”) of $258
million
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